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We are seeking a highly skilled Regional Quality Assurance Specialist to join our EMEA Regional Quality Assurance team. In this role, you will be responsible for planning and coordinating all quality-related activities associated with our Economic Operators and the planning and support of Internal and External Audits to maintain our ISO13485 certifications in the region.
Key Responsibilities:
- Process Development and Improvement: Design, develop, and sustain compliant processes and procedures in support of global quality operations while involving the appropriate functional groups in communications and decision making.
- NCR/CAPA Activities: Initiate NCR/CAPA activities as required, including identification of root cause, action planning, and post-implementation effectiveness checks.
- Regulatory Compliance: Have an understanding of regional regulatory needs and requirements, provide input to gap analysis of regulation updates (e.g. ISO 13485, EU MDR, etc.).
- Audit Support: Support and perform internal and external audits as appropriate (e.g. 3PL, distributors, importers, OEMs, suppliers).
- Quality System Training: Delivery of appropriate Quality System training to associates and/or third-party employees according to business needs.
- Quality Reporting: Initiate change documentation and prepare quality reports and presentations, including input to Trend Review Boards and Management Review.
- Collaboration and Communication: Coordinate with and provide QA support to other regional and global functions (e.g. Distribution and Logistics, Customer Service, Sales Contracts, Regulatory, Product Surveillance Group, Labelling, Field Action Teams, etc.).
- Quality Objectives and Resource Planning: Assist in the development and execution of global and regional quality objectives and resource plans.
Required Qualifications:
- At least 4 years of experience in the medical device or life-science industry in developing, implementing, and maintaining quality systems.
- Demonstrated strong technical capability.
- Effective interpersonal skills with experience collaborating effectively across functions and establishing key relationships.
- Knowledge of ISO 13485 and EU MDR.
- Ability to multitask, prioritize, and meet deadlines.
- Ability to work alone or as part of a diverse team.
- Fluent in English with strong verbal and written communication skills.
- Strong organizational skills and detail-oriented while being flexible and able to adapt to changing priorities.
Desired Qualifications:
- QA experience in Manufacturing, Distribution, or Customer Service organizations, and Economic operator processes.
- Auditing skills and experience.
- Certified Quality Auditor.
What We Offer:
We provide a comprehensive and competitive total rewards program that supports your everyday and helps you build your tomorrow. Our benefits offer choice and flexibility and promote overall well-being. We also provide a distinctive Associate Stock Ownership Plan and potential opportunities for profit-sharing.
We believe in the strength of a diverse and inclusive workplace. With diverse perspectives, ideas, and experiences, we uncover new possibilities and make a greater impact in the world. We are proud of our Associates for building on our rich history of innovation, upholding our values, and supporting an inclusive work environment where we treat each other and our external partners with fairness, dignity, and respect.
We are an equal opportunity employer and welcome all applications irrespective of race, color, religion, sex, gender, national origin, ancestry, age, status as a qualified individual with a disability, genetic information, pregnancy status, medical condition, marital status, sexual orientation, status as a covered veteran, gender identity, and expression, and any other characteristic protected by applicable laws and regulations.